Industria Pesquera Mediterraneo
⚠️ Moderate Risk
FEI: 3006891753 • San Jose • GUATEMALA
FEI Number
3006891753
Location
San Jose
Country
GUATEMALAAddress
Barrio El Laberinto Lote 2, , San Jose, , Guatemala
Moderate Risk
FDA Import Risk Assessment
This firm has a moderate history of FDA import refusals. Some attention may be warranted.
Statistics
Score Breakdown
How is this score calculated?
Proprietary Algorithm
- 40% Violation Severity — AI-assessed (1-10)
- 30% Refusal Volume — Logarithmic scale
- 20% Recency — Decays over 5 years
- 10% Frequency — Refusals per year
© ImportRefusal.com Original Analysis
Violation Summary
FILTHY
The article is subject to refusal of admission pursuant to Section 801(a)(3) in that the article appears to consist in whole or in part of a filthy, putrid, or decomposed substance or be otherwise unfit for food.
PRESRV LBL
The article is subject to refusal of admission pursuant to Section 801(a)(3) in that it appears to contain a chemical preservative and it fails to bear labeling stating that fact including its function.
NO ENGLISH
Required label or labeling appears to not be in English in violation of 21 C.F.R. 201.15(c)(1).
UNAPPROVED
The article is subject to refusal of admission pursuant to Section 801(a)(3) in that it appears to be a new drug within the meaning of Section 201(p) without an approved New Drug Application (NDA).
RX LEGEND
The article appears to be a prescription drug without a prescription drug legend as required by Section 503(b)(4).
Refusal History
| Date | Product | Violations | Division |
|---|---|---|---|
| 10/12/2010 | 61TDK02BUCLIZINE HCL (ANTI-EMETIC/NAUSEANT) | Division of Southeast Imports (DSEI) | |
| 2/19/2010 | 16SFH73MACKEREL (ALL EXCEPT SCOMBEROMORUS SP, EG SPANISH OR KING SEE '22'), COLD SMOKED, FISH | 276PRESRV LBL | Florida District Office (FLA-DO) |
| 6/24/2009 | 16SFH73MACKEREL (ALL EXCEPT SCOMBEROMORUS SP, EG SPANISH OR KING SEE '22'), COLD SMOKED, FISH | 249FILTHY | Florida District Office (FLA-DO) |
Frequently Asked Questions
What is Industria Pesquera Mediterraneo's FDA import refusal history?
Industria Pesquera Mediterraneo (FEI: 3006891753) has 3 FDA import refusal record(s) in our database, spanning from 6/24/2009 to 10/12/2010.
What is an FEI number?
FEI stands for Firm Establishment Identifier. It's a unique number assigned by the FDA to identify establishments that manufacture, process, pack, or hold food, drugs, medical devices, or other FDA-regulated products. Industria Pesquera Mediterraneo's FEI number is 3006891753.
What types of violations has Industria Pesquera Mediterraneo received?
Industria Pesquera Mediterraneo has been cited for 5 different violation type(s). Common FDA violations include adulteration (unsafe or unsanitary products), misbranding (incorrect or misleading labels), and regulatory non-compliance.
Where does this information about Industria Pesquera Mediterraneo come from?
All FDA import refusal data for Industria Pesquera Mediterraneo is sourced from the official FDA Data Dashboard (datadashboard.fda.gov), a public government database maintained by the U.S. Food and Drug Administration.
Data sourced from the FDA Data Dashboard, a public database maintained by the U.S. Food and Drug Administration.